On 24 May Roche, the manufacturers of Herceptin (Trastuzumab), announced that the European Commission had granted a licence extension for Herceptin to include use in patients with HER2-positive early-stage breast cancer.
On 9 June, the National Institute for Health and Clinical Excellence (NICE) published its draft guidance on Herceptin. This recommends the drug for women with early-stage HER2-positive breast cancer, except where there are concerns about cardiac function. The full draft recommendations are as follows:
1.1 Trastuzumab, given at three week intervals for one year or until disease recurrence (whichever is the shorter period), is recommended as a treatment option for women with early-stage HER2-positive breast cancer following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable).
1.2 Cardiac function should be assessed prior to the commencement of therapy and trastuzumab treatment should not be offered to women who have a left ventricular ejection fraction (LVEF) of 55 per cent or less, or who have any of the following:
a history of documented congestive heart failure;
high-risk uncontrolled arrhythmias;
angina pectoris requiring medication;
clinically significant valvular disease;
evidence of transmural infarction on electrocardiograph (ECG);
poorly controlled hypertension.
1.3 Cardiac functional assessments should be repeated every three months during trastuzumab treatment. If the LVEF drops by 10 per cent. from baseline and to below 50 per cent. then trastuzumab treatment should be suspended. A decision to resume trastuzumab therapy should be based on a further cardiac assessment and a fully informed discussion of the risks and benefits between the individual patient and their clinician.
These recommendations are subject to an appeal period which closes on 28 June 2006. During this period, registered stakeholder organisations including those representing healthcare professionals, patients and carers can appeal against the draft guidance. Final guidance is expected to be issued at the beginning of July 2006, assuming there are no appeals.
Once finalised, the recommendations will mean that all eligible patients with early-stage HER2-positive breast cancer should receive Herceptin on the NHS. Although the recommendations are subject to appeal, there are no national restrictions on the NHS using Herceptin in the interim and the draft recommendations should, of course, be taken into account by Primary Care Trusts.
I would like to congratulate NICE on issuing its draft recommendations on Herceptin just two weeks after the drug was licensed for use in early-stage breast cancer. This shows how the new single technology appraisal process allows NICE to issue guidance within weeks of a licence being granted.
The important thing now is for NHS cancer networks to ensure that all women diagnosed with early-stage breast cancer receive a HER2 test to determine if they are HER2-positive and might therefore benefit from treatment with Herceptin.
Professor Mike Richards, the National Cancer Director, is already working with cancer networks to ensure that testing arrangements are put in place. I am expecting an update from Professor Richards next week and I will ensure that both Houses receive a report on progress soon afterwards.